510(k) Report

510(k) · Cleared

Cleared

Relieva Sinus Balloon Inflation Device

K052198510(k) TraditionalCleared Aug 31, 200519-day reviewClass I21 CFR 874.4420

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Acclarent, Inc. · LRC Instrument, Ent Manual Surgical

Cleared on Aug 31, 2005 as substantially equivalent to K043527 (Exploramed Nc1, Inc., 2005) after a 19-day review. Its family tree reaches back 1 generation to 2005. 6 later devices descend from it.

Decided
Aug 31, 2005
Review
19 days
Class
Class I
Product code
LRC
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K043527 (2005). 6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2015: 2 descendants cleared2009: 1 descendant cleared2011: 1 descendant cleared2016: 1 descendant cleared2023: 1 descendant clearedK043527 · Relieva Sinus Balloon Dilation Catheter · Exploramed Nc1, Inc. · 200520052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 4 descendants K043527 · Relieva Sinus Balloon Dilation Catheter · Exploramed Nc1, Inc. · 20050
  1. Root · 1 generation backK043527 Relieva Sinus Balloon Dilation CatheterExploramed Nc1, Inc. · 2005
  2. This deviceK052198 Relieva Sinus Balloon Inflation DeviceAcclarent, Inc. · 2005
  3. Descendant · cites it directly · 4 of its ownK090660 Airway Balloon Catheter Inflation DeviceAcclarent, Inc. · 2009 · Recalled
  4. Descendant · 2 generations on · 1 of its ownK150951 aeris Balloon Dialation CatheterBryan Medical, Inc. · 2015 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK231818 METIC™- Airway Balloon CatheterM/S Meril Life Sciences Pvt., Ltd. · 2023
  6. Descendant · 2 generations on · 0 of its ownK153484 Dillard Airway Dilatation SystemIntuit Medical Products, LLC · 2016
  7. Descendant · cites it directly · 0 of its ownK150172 ACCLARENT SE Inflation DeviceAcclarent, Inc. · 2015

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12015: 22016: 12023: 1
2009high 2 (2015) · low 0 (2010)2026

Most influential descendants

Showing 5 of 6 · See all
  • K090660Airway Balloon Catheter Inflation DeviceAcclarent, Inc. · 2009 · cites it directly4descendants
  • K150951aeris Balloon Dialation CatheterBryan Medical, Inc. · 2015 · 2 generations on1descendant
  • K231818METIC™- Airway Balloon CatheterM/S Meril Life Sciences Pvt., Ltd. · 2023 · 2 generations on0descendants
  • K153484Dillard Airway Dilatation SystemIntuit Medical Products, LLC · 2016 · 2 generations on0descendants
  • K150172ACCLARENT SE Inflation DeviceAcclarent, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K043527Relieva Sinus Balloon Dilation CatheterExploramed Nc1, Inc.2005—
0 (this device)K052198Relieva Sinus Balloon Inflation DeviceAcclarent, Inc.2005—
+1K090660Airway Balloon Catheter Inflation DeviceAcclarent, Inc.20097
+2K150951aeris Balloon Dialation CatheterBryan Medical, Inc.20151
+2K231818METIC™- Airway Balloon CatheterM/S Meril Life Sciences Pvt., Ltd.2023—
+2K153484Dillard Airway Dilatation SystemIntuit Medical Products, LLC2016—
+1K150172ACCLARENT SE Inflation DeviceAcclarent, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201520
201610
202310
FIG. 1 — Lineage of K052198, 2005–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LRC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LRC device

  1. #1 K230258 BB 8 Sinus Dilation Kitscore 11.1 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K043527Relieva Sinus Balloon Dilation Catheter
Summary page 2
…America America _510(k) Number K052 198 K043527 Pre-Amendments Pre-Amendments CFR Section 874.4420 874.4420…
Exploramed Nc1, Inc.2005—

Also cleared against K043527: 3 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090660Airway Balloon Catheter Inflation DeviceAcclarent, Inc.20094
K150172ACCLARENT SE Inflation DeviceAcclarent, Inc.20150

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K090660 (Acclarent, Inc., 2009) has gone furthest, with 4 descendants of its own.
  • 3 other devices also cite its predicate K043527.

How does its category compare?

All LRC devices

LRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LRC

1in 2023

2008: 22009: 12010: 22011: 62012: 72013: 72014: 32015: 62016: 32017: 22018: 12019: 12020: 42022: 12023: 1
2007high 7 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LRC

131in 2020

2011: 106 days median2012: 50 days median2013: 104 days median2014: 29 days median2015: 105 days median2016: 100 days median2020: 131 days median
2007high 131 (2020) · low 29 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LRC

1in 2024

2023: 12024: 1
2007high 1 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LRC

44in 2025

2007: 12009: 82010: 112011: 142012: 482013: 532014: 532015: 412016: 392017: 322018: 422019: 192020: 202021: 232022: 252023: 142024: 512025: 44
2007high 53 (2013) · low 0 (2008)2025

MAUDE reports naming product code LRC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20082—00
20091—08
20102—011
20116106014
2012750048
20137104053
2014329053
20156105041
20163100039
20172—032
20181—042
20191—019
20204131020
20210—023
20221—025
20231—114
20240—151
20250—044
20260—0—

What is it indicated for?

The Relieva Sinus Balloon Inflation Device is recommended for use to inflate the balloon, monitor the pressure within the balloon and deflate the balloon while performing balloon dilation procedures of the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

Indications for use as stated in the FDA summary.

Also cleared against K043527

3 other devices cite the same predicate.

  • K072302Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
  • K073041Relieva and Relieva Acella Sinus Balloon CatheterAcclarent, Inc. · 2008
  • K061903Relieva Sinus Balloon CatheterAcclarent, Inc. · 2006

More from Acclarent, Inc.

45 FDA decisions under this applicant name. See the company

  • K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc. · 2026
  • K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc. · 2023
  • K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc. · 20231 recall
  • K221037TruDi Shaver BladeAcclarent, Inc. · 2022
  • K201115Next Generation Balloon Dilation SystemAcclarent, Inc. · 2020

Recent decisions in LRC

The LRC category page

  • K230258BB 8 Sinus Dilation KitExcelent, Inc. · 2023
  • K212774VenSure LightGuideIntersect Ent. · 2022
  • K201398SINUSPRIME Dilation SystemStryker Ent · 2020
  • K201115Next Generation Balloon Dilation SystemAcclarent, Inc. · 2020
  • K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH · 2020

https://510kreport.com/device/K052198 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052198: Relieva Sinus Balloon Inflation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052198

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026